Recall Z-2550-2020 ยท OWL Peripheral Catheter Insertion Kit
Access Scientific LLC
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection
| Date | Jun 15, 2020 |
| Status | Terminated |
| Reason | Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance. |
| Root cause | Labeling Change Control |
| Action | On 06/15/2020, the firm notified affected customers via email and/or overnight mail of "URGENT: MEDICAL DEVICE RECALL" letter indicating the following: Immediately examine your inventory and quarantine product subject to correction. In addition, if you may have further distributed this product, please identify your customers and notify them a once of this product correction. Your notification to you customers may be enhanced by including a copy of this notification letter. Please take the following actions: 1. Review your inventory for the catalog and lot numbers specified in this notificat |
| Quantity | 1710 |
| Distribution | US Nationwide distribution including in the state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.